Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

August 2026 — CDMO Opportunities And Threats Report

Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

GUEST COLUMNISTS

What FDA Inspectors Want From Your OOS File
Read enough FDA warning letters and a pattern emerges: Investigators rarely cite a retest that was performed badly. They cite a retest that nobody justified in writing. Let's take a closer look.
You Can't CAPA What You Can't Classify
An LLM or agentic error can occur with no component broken in any way the QMS recognizes. Classifying it takes two fields: the error type and the error origination point.
AI Fills The Decision-Making Gaps In Process Analytical Technology
When combined, artificial intelligence and PAT help move beyond reactive quality testing to proactive and anticipatory process management.
Is mRNA Manufacturing Overbuilt?
mRNA pipelines continue to advance, but has provider growth outpaced the pipeline? Let's take a closer look.
CDMO Quality Oversight: How FDA And Pharma Leaders Are Rethinking Data, AI, And Culture
Discover strategies for risk-based governance, AI-enabled quality management, stronger collaboration, and fostering a culture that supports long-term operational excellence.
Using Digital Platforms To Find Your CDMO
In recent years, digital platforms have emerged to help pharma/biotech companies discover, evaluate, and connect with CDMOs more efficiently. These resources have different functions and limitations.
FDA Issues New Guidance On Therapeutic Equivalence
The FDA has issued a new guidance document, Evaluation of Therapeutic Equivalence, clarifying the scientific and regulatory principles. What does this mean for drug developers and manufacturers?
July 2026 — CDMO Opportunities And Threats Report
Each month, Outsourced Pharma works in conjunction with PharmSource, part of GlobalData, to present its “Contract Manufacturing: Opportunities and Threats (CMOT) Report” to our readers. The report identifies CDMOs that might be impacted by key events affecting their clients, including company acquisitions, product acquisitions and licenses, product approvals, late clinical product terminations, and FDA rejections.

PHARMA OUTSOURCING WHITE PAPERS

Optimizing Charge And N-glycan Profiles For CHO-Derived Fusion Proteins
Discover how structured design-of-experiment approaches can optimize charge variants and glycosylation to enhance biologics quality and therapeutic performance.

Overview Of Hot Melt Extrusion And Its Pharmaceutical Applications
More than 40% of NCEs face aqueous solubility challenges. Here, we examine how hot melt extrusion addresses solubility, modified release, abuse deterrence, and scale-up across pharmaceutical development.
How Integration Is Redefining Speed, Scale, And Sustainability
Integrated manufacturing ecosystems help biologics programs adapt to changing demand across the product lifecycle. Discover flexible scaling strategies that improve speed, efficiency, and sustainability.
Quality By Design (QbD) For Biologics From A CDMO Perspective
Adopt QbD principles in your biologics development and manufacturing process to ensure consistent product quality, mitigate risks, and align with patient safety and commercial success goals.
EMA Support For Rare Disease Therapies
Review how the EMA supports rare disease drug development through regulatory and financial incentives for therapies that meet strict eligibility and ongoing compliance criteria.
Innovations In API Manufacturing Of Small Molecule Drugs
Read how advances in people, processes, technology, materials, analytics, and sustainability are reshaping small‑molecule API manufacturing to reduce costs, scale efficiently, and meet future demand.